The latest version of Annex 11 was published in January 2011 and comes into effect in June 2011. This may require Regulated Companies selling pharmaceutical and veterinary products into the European Union to review their current approach to the implementation, use, maintenance and support of computerised systems.

On this page you can find a copy of the English version of the revised guidance. Other officially translated versions will become available via the Eudralex Volume 4 webpage. We have posted an unofficial (but carefully prepared and reviewed) French translation of the new Annex 11, prepared by Yves Samson (Director at Kereon AG in Basle Switzerland). Yves was also responsible for preparing the French version of the GAMP® Guide and is a leading light in GAMP® Francophone.

You can also download a cross-walk document, prepared by respected industry professional Orlando Lopez, comparing the requirements of the new Annex 11 with Chapter 21 of the US Code of Federal Regulations (Parts 11, 211 and 820), the PIC/S PI-011 guidance document and other guidance. This document is being currently updated with input from other industry professionals

We thank both Yves and Orlando for their time in preparing these documents and for allowing us to make them available to a wider audience. All documents are available by clicking on the links to the lower right.

You can also view a special Business & Decision Life Sciences webcast on the new Annex 11 guidance by following the relevant link, to the left of the page.

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